FDA Adverse Event Malfunction Summary report: N

IMPL TAPERED SP 3.7MM 12M M OCTAGON

MDR report key: 10640895 · Received October 7, 2020

Report

Report Number: 0002023141-2020-01580
Event Type: Malfunction
Date Received: October 7, 2020
Date of Event: January 8, 2020
Report Date: October 7, 2020
Manufacturer: ZIMMER DENTAL
Product Code: DZE
UDI-DI: 00889024017184
PMA / PMN Number: K082639
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: DENTIST

Narratives

Additional Manufacturer Narrative · 1

ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PREMARKET IDENTIFICATION PMA/510(K) NUMBER K011245 AND K002188. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR PERI-IMPLANTITIS EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR THESE EVENTS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF A MANUFACTURING OR DESIGN DEFECT THAT MIGHT LEAD TO PERI-IMPLANTITIS OCCURRING AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED. SUMMARY INVESTIGATION.

Description of Event or Problem · 1

DOCTOR REPORTED THE IMPLANT IN TOOTH LOCATION #34 WAS REMOVED DUE TO PERI-IMPLANTITIS AND BONE LOSS. SITE PRESENTED EDEMA AND INFLAMMATION. PATIENT HAD PAIN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1106059	IMPL TAPERED SP 3.7MM 12M M OCTAGON	DENTAL IMPLANT	DZE	ZIMMER DENTAL	SPB12	0500237	00889024017184

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Required Intervention